Abbott begins enrolment in TTVR system’s trial for tricuspid regurgitation
Abbott has started patient enrolment in a new clinical trial (TRILUMINATE) to evaluate its transcatheter tricuspid valve repair (TTVR) system in patients with moderate or severe tricuspid regurgitation (TR).
The TTVR device is a minimally invasive clip-based repair system designed based on the firm’s MitraClip System that has been proven to effectively treat mitral regurgitation.
TR occurs when the valve between the heart's two right side chambers does not close properly leading to a backward flow of blood into the right atrium, while mitral regurgitation impacts the left side of the heart.
If left untreated, the conditions might result in atrial fibrillation, heart failure and ultimately death.
The prospective, single-arm, multi-centre TRILUMINATE trial will assess the TTVR system’s safety, efficacy and performance in up to 75 symptomatic patients at 25 clinical sites in the US and Europe.
The first patient for the trial was enrolled at Abbott Northwestern Hospital in Minneapolis, US.
Abbott Vascular and Structural Heart businesses Global Medical Affairs chief medical officer and divisional vice-president Charles Simonton said: "The investigational medical device that will be used in this study builds on years of learning and knowledge using our clip-based device for treating mitral regurgitation.
“We look forward to the results of the trial to determine if this new minimally invasive technology has the potential to benefit people living with tricuspid regurgitation just as predictably."
The findings from the TRILUMINATE trial are expected to support the firm’s application for CE-Mark of the clip-based TTVR system in Europe.